Regulating reliably: building high-reliability regulators in healthcare (24 January 2025)

Summary

Regulation and regulators play a critical role in assuring the quality and safety of care, and undertake a range of influential activities. This includes setting appropriate standards of care; assessing and monitoring care actually being delivered within healthcare systems, often through intensive data collection and inspection; intervening when standards of care are suboptimal, with options ranging from supportive guidance to legal sanction; and, perhaps most fundamentally, determining whether organisations and practitioners can provide care in the first place, through licensing and registration.

Healthcare organisations and practitioners are heavily scrutinised by an array of these external regulatory actors and activities. There are around 126 different oversight bodies in the NHS that have some role in assessing, monitoring and regulating patient safety. Despite this – and indeed, likely in part due to this supervisory complexity – disastrous care failures still happen with distressing regularity, with healthcare regulators often identified as having missed or misunderstood the emerging signs of impending failure.

This situation poses an urgent set of questions. How can regulators, and the regulatory work that they do, be organised in ways that: enable close and attentive monitoring of the complex activities of delivering care; support constructive, honest but appropriately challenging interactions with healthcare organisations and practitioners; and facilitate ongoing improvement and learning – both within healthcare organisations and regulators themselves?